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The present invention relates to (1) an improved process for the production of an arginine-silicate-polyol complex and to (2) low copper, low iron, and/or low heavy metals argenine-silicate-polyol complexes.
Atherosclerosis is a complex and chronic disease involving the gradual accumulation of lipids, collagen, elastic fibers and proteoglycans in the arterial wall. Current methods of managing atherosclerosis include a low-fat diet, exercise and various cholesterol-lowering drugs. Although these methods can significantly retard the progression of atherosclerosis, they are not entirely satisfactory. U.S. Pat. Nos. 5,707,970; 6,156,735; and 6,344,444 (all of which are incorporated by reference herein in their entirety) teach the utility of arginine-silicate-inositol complexes as well as arginine-silicate-sugar alcohol complexes for the treatment of these conditions. These patents disclose that arginine is combined with inositol or a sugar alcohol and a silicate salt to form a suspension and heated to promote gel formation. The gel is allowed to crystallize and alcohol is added to promote crystallization. The alcohol must ultimately be removed and the removal of the alcohol (which can be up to about 50% of the mass) can be hazardous. In addition, the product that results is an extremely hard material that requires extensive (and expensive) efforts at milling and considerable energy input in order to obtain commercially desirable product. Hence, there is a need to develop improved manufacturing methods that will allow for commercially viable product at a reasonable cost.
It is therefore an object of the invention to provide an improved process for the manufacture of arginine-silicate complexes that avoid the problems of the art.
It is a further object of the invention to provide a method of making arginine-silicate complexes that are commercial batch size viable.
It is yet another object of the invention to provide a process of making arginine-silicate complexes that avoids the use of counter solvents such as ethanol.
Still other objects of the invention will be apparent to those of ordinary skill in the art.
Surprisingly, it has been found that the above objects can be readily achieved by avoiding the gelling and crystallization steps as set forth in U.S. Pat. Nos. 5,707,970, 6,156,735; and 6,344,444 and spray drying a solution of the arginine-silicate-inositol complex or arginine-silicate-sugar alcohol complex. In one embodiment of the invention, the arginine, silicate salt, and either the inositol or sugar alcohol are combined at elevated temperature to form an initial solution or suspension. The initial solution or suspension is ultimately raised to about at least 80xc2x0 C. In contrast to U.S. Pat. No. 5,707,970 and its continuation patents, the solution is not permitted to gel and crystallize, nor is a counter solvent added, but rather, while maintaining the complex in solution, the solution is spray dried to result in the desired product.
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